Kornimate/medical-research-clean huggingface dataset:
telehealth referral to improve outcomes

Conditions: Hypertension

Summary: emergency patients often have uncontrolled asymptomatic hypertension upon discharge from the emergency department. this 3-arm randomized controlled trial will evaluate the impact of nurse telehealth encounters and remote patient monitoring, using a software called vital tech, on blood pressure control and primary care engagement.

emergency department (ed) clinicians encounter patients with asymptomatic hypertension (htn) on a daily basis but usually fail to intervene. this pilot study will determine the utility of a novel intervention: telehealth referral to improve outcomes (trio), a conceptually driven information technology tool focused on patients who are asymptomatic and hypertensive upon ed discharge. it is designed to successfully link them to a primary care provider (pcp) after ed discharge to improve blood pressure (bp) control. 48 adult ed patients who have asymptomatic htn (bp \>/= 140/90 mmg and \</= 180/120 mmhg) and who will be discharged will be enrolled in the study. this study is a single-site, 3-arm randomized controlled pilot trial. all patients will receive a wireless bp monitor and tablet. group 2 (n=16) will additionally receive a telehealth consult with an rn at day 3. group 3 (n=16) will additionally receive a telehealth consult with an rn at day 3 and day 7. the research team will collect feasibility outcomes: (recruitment rate, retention rate, and attrition rate of patients enrolled in trio at 6-months and 12-months. the research team will evaluate bp control and engagement with primary care at 6-months and 12-months and compare between groups.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * at least two\* high blood pressure readings during ed visit 1. systolic (top #) ≥140, ≤180 and/or 2. diastolic (bottom #) ≥ 90, ≤120 \*second blood pressure may be confirmed when approaching the patient. before approaching, check exclusions first. exclusion criteria: * symptomatic hypertension

Keywords: asymptomatic hypertension referral telehealth remote patient monitoring emergency department blood pressure
the effect of cold exposure on energy expenditure

Conditions: Cold Exposure

Summary: cold-induced thermogenesis, or the increase in energy expenditure upon cold exposure, indicates metabolic stress, as such, cold-induced thermogenesis may signal an appropriate stimulus to improve metabolic health. cold acclimation may alter cold-induced thermogenesis due to changes in (non)shivering thermogenesis and blood flow. the main aim of this research is to compare the energy expenditure responses, during a standardised cold stress (\~ 9°c air temperature, maximum 1 hour), of siberian adults with western european adults. the subjects will be individually matched for age, sex, body mass and height. it was hypothesised that cold-induced thermogenesis will be reduced in the siberian population.


Eligibility criteria:
inclusion criteria: * signed informed consent * western european origin or of siberian origin * bmi between 18.5 and 35 kg/m2 * generally healthy (determined by dependent physician) exclusion criteria: * smoking * active, uncontrolled cardiovascular disease or cancer * raynaud's disease * participation in another biomedical study within 1 month before the first study * cold-acclimated (western european group), such as takes daily extended cold baths, works in a refrigerated environment, or regular cold-water swimming within 1 month of starting the study * medication use known to hamper subject's safety during study procedures * abuse of alcohol or drugs

Keywords: cold exposure energy expenditure
the patient preference analysis of yearly follow-up after pci (papaya)

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to determine the preference of patients regarding the approach for follow-up after percutaneous coronary intervention (pci) procedures. we hypothesize that patients prefer questionnaires for annual follow-up assessment when compared to telephone or email.

rationale: assessment and reporting of long-term clinical follow-up after medical interventions is essential for transparency of medical care and its quality improvement. however follow-up adherence is a serious challenge in clinical trials. taking the patient preference of the mode of follow-up into account is likely to enhance trial adherence, reduce withdrawals, and facilitate a longer follow-up duration. no data on patient preference of annual follow-up have been reported. objective: to investigate the patient preference of approach to obtain follow-up information after percutaneous coronary intervention (pci) study design: single-center, prospective, observational registry study population: all patients enrolled in the percutaneous coronary intervention studies twente trial (a broad study population reflecting real-world pci patients) and dutch peers trial (an all-comers population), who were treated at thoraxcentrum twente in enschede between june 2008 and may 2012 intervention: all subjects will receive a questionnaire with questions regarding their preference with regards to the approach of acquiring follow-up information after pci. main study endpoints: * the primary endpoint is the patient preference on how to be approached for annual follow-up after pci procedures. * secondary endpoints include 1. least preferred approach of follow-up 2. the preferred number of follow-up moments per year 3. the from the patients' perspective maximum acceptable number of questions to be answered 4. the assessment of potential relationships between the most and least preferred approach of assessment and patient age, gender urgency of pci treatment, and history of previous revascularizations

Eligibility criteria:
inclusion criteria: * all patients enrolled in the twente trial and dutch peers trial (an all-comers population, who were treated at thoraxcentrum twente in enschede between june 2008 and may 2012 exclusion criteria: * patients who had withdrawn their consent for participation in the twente and dutch peers trials, respectively. patients who passed away during follow-up could obviously not be approached for further questioning.

Keywords: follow-up percutaneous coronary intervention patient preference dutch peers twente
endobronchial ultrasound-guided transbronchial needle-aspiration with suction in obtaining samples from patients with suspected nodal metastatic lung cancer

Conditions: Lung Carcinoma

Summary: this trial studies how well endobronchial ultrasound-guided transbronchial needle-aspiration (ebus-tbna) with suction works in obtaining samples from patients with suspected lung cancer that has spread to the nodal. ebus-tbna samples obtained with additional suction may help to improve material-amounts and decrease blood contamination in the samples.

primary objectives: i. to evaluate if suction applied with a vacuum syringe during ebus-tbna sampling helps to obtain more material for molecular analyses. outline: patients undergo bronchoscopy with ebus-tbua first without and then with applied vacuum.

Eligibility criteria:
inclusion criteria: * computed tomography (ct)-scan finding suspicious for lung cancer with nodal metastases * clinically stable to undergo diagnostic workup by bronchoscopy with endobronchial ultrasound exclusion criteria: * pregnant female * minors * prisoners * patients with contraindication for ebus such as non-reversible anticoagulation
impact of anesthesia on the dimension of the ascending aorta

Conditions: Aortic Aneurysm, Thoracic

Summary: the aim of this study is to evaluate the accuracy and reliability of intra-operative tee after the induction of anesthesia when assessing proximal thoracic aorta diameters in a cohort of aortic aneurysm patients.

dilatation of the ascending aorta often progresses silently in an asymptomatic patient, until an acute complication occurs (such as a dissection or rupture), which is directly related to the diameter of the aortic. to prevent these extremely harmful situations, aortic replacement surgery, as indicated by significant dilatation of the ascending aorta, could be the option of choice (1). the decision to perform elective surgery depends on the measurement of the thoracic aorta diameter, which would rely on the largest aortic dimension. trans-thoracic echocardiography (tte) is widely used to assess the aortic root (2), and results from computed tomography (ct) scans are used to evaluate the ascending aorta beyond the sinotubular junction (3, 4). both these tests facilitate follow-up evaluation of patients with thoracic aortic aneurysm. usually, patients are referred for surgery based on the findings of one or both of these examinations. furthermore, when a patient is referred for surgery, intra-operative trans-esophageal echocardiography (tee) is often performed after induction of the anesthesia in order to evaluate the aortic dimension and valve function. in some cases, the diameter of the aorta is considered borderline for replacement, in which case the tee measurement could reverse the decision-making, especially when the indication for surgery is due to valve pathology, with the aorta being a secondary consideration. from the investigators experience, intra-operative tee aortic measurements after the anesthesia are not entirely accurate, and could under-estimate the diameter of the aorta. relying on intra-operative tee measurements could result in under-treatment of the dilated aorta, especially when its replacement is secondary to other cardiac pathologies (e.g. avr, cabg) that require surgery. influence of intra-operative anesthesia on tee measurements of the aorta are not described in the current literature. if the investigators hypothesis is correct, adjustments will need to be made regarding the surgical management of patients with borderline aortic dimensions.

Eligibility criteria:
inclusion criteria: * ascending aorta of 40 mm and above * patients who undergo cardiac surgery exclusion criteria: * unstable patients * patients who underwent a previous cardiac surgery * patients who were diagnosed with aortic dissection
on-eye optical quality of lotrafilcon b lenses over 12 hours

Conditions: Hyperopia; Myopia

Summary: the current study aims to systematically investigate the diurnal variation in the optical quality of soft contact lenses on eye throughout the day. subject reported quality of vision will also be evaluated.


Eligibility criteria:
inclusion criteria: * habitual prescription +5.00 d to -6.00 d * 18-35 years of age * the subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. * vertex corrected refractive cylinder must be -0.75 or less. * visual acuity best correctable to 20/25 or better for each eye * the subject must read and sign the informed consent form. * mesopic pupil size \>5.00 mm. exclusion criteria: * active condition that would prevent contact lens wear * history of issues of eye alignment or binocularity by self-report * doctor diagnosed, self-reported accommodative or binocular vision issues * doctor diagnosed, self-reported ocular surface disease or dry eye requiring regular, ongoing treatment
evaluation of endogenous pain modulation mechanisms with transcutaneous electrical nerve stimulation

Conditions: Chronic Pain

Summary: a number of chronic pain conditions are characterized by imbalances in excitatory and/or inhibitory mechanisms and these deficits appear correlated with the response to certain treatments. evaluating these mechanisms among people who suffer from chronic pain could allow clinicians to adapt the treatment to each patient according to the deficits observed. to evaluate excitatory and inhibitory mechanisms, a thermode (hot plate) and a cold water bath can be used (standardized protocol). unfortunately, these tools are expensive, time-consuming and require complex equipment and software. as such, it is not realistic for clinicians to use them for routine patient assessment. a potential alternative to study these mechanisms is tens (transcutaneous electrical nerve stimulation). tens is frequently used in rehabilitation and unlike thermode and cold water bath, is affordable, easy to use and requires very little time and equipment. the objective of this study are to determine if the tens can replace the thermode and cold water bath (standardized protocol) for the evaluation of excitatory and inhibitory mechanisms. also, to determine if there will be a correlation with the standardized protocol. 50 healthy participants between 18 and 60 years old will participate in this study. each participant will attend two experimental sessions. in one of the two sessions, the evaluation will be done with the tens; in the other session, the evaluation will be done with the standardized protocol (thermode and cold water bath).

to evaluate excitatory and inhibitory mechanisms, the investigators will used the modified cpm testing procedure consisting of test stimulus (ts) administered before and after a conditioning stimulus (cs). for the standardized protocol, the ts will consisted of a noxius heat stimulus generated by a thermode (hot plate), applied for two minutes on the non-dominant anterior forearm. the cs will consisted of a cold pressor test (ct), wherein participants immersed their dominant forearm in a cold water bath for two minutes. for the tens protocol, the ts will consisted of a noxius electrical stimulus generated by tens, applied for 5 seconds on the non-dominant knee at a frequency of 1 hz and 5 hz. the cs will consisted of a noxius electrical stimulus generated by tens' applied for 120 seconds on the non dominant knee and ankle at a frequency of 2 hz.

Eligibility criteria:
inclusion criteria: * man or woman between 18 and 60 years old (inclusive) exclusion criteria: * chronic pain * neurological disorders * musculoskeletal disorders * depression * raynaud syndrome * history of non-efficacy with tens * history of epilepsy * presence of a pacemaker or metal implants * antidepressant * anticonvulsant * analgesics * caffeine

Keywords: excitatory mechanisms inhibitory mechanisms thermode(hot plate) cold water bath transcutaneous electrical nerve stimulation (tens)
a clinical evaluation of the sinexus intranasal splint following functional endoscopic sinus surgery in patients with chronic rhinosinusitis

Conditions: Chronic Sinusitis

Summary: the purpose of this study is to assess the safety and performance of the sinexus intranasal splint when used following functional endoscopic sinus surgery (fess) in patients with chronic rhinosinusitis.

this was a prospective, multi-center, double blind trial that enrolled patients in three groups as described below. two groups (pilot 15 mm and efficacy 25 mm) used a randomized, double-blind, intra-patient control study design to assess performance of the drug-coated splint (received in one ethmoid sinus) compared to the control splint (received in the contralateral ethmoid). the other group of patients (safety/pk 25 mm) received bilateral drug-coated splints, and served as a pharmacokinetics (pk) study group.

Eligibility criteria:
inclusion criteria: * patient is 18 years of age or older. * patient has a diagnosis of bilateral crs defined as inflammation of the mucosa of the nose and paranasal sinuses of at least 12 consecutive weeks' duration. * patient has a clinical indication for and has consented to bilateral fess. * crs diagnosis documented by ct scan within 60 days of the procedure. * patient has minimal total ct stage (lund-mackay method) of 6. * patient has bilateral disease defined as minimal ct stage per side of ≥3. exclusion criteria: * oral-steroid dependent copd, asthma or other condition. * immune deficiency (igg subclass deficiency or iga deficiency). * symptomatic coronary artery disease. * patient undergoing chemotherapy treatment. * morbid obesity (bmi \> 40) or a bmi that, in the opinion of the physician, would compromise health and participation in the study. * evidence of active infection.
tesetaxel as first-line therapy for metastatic breast cancer

Conditions: Breast Neoplasm

Summary: the intravenously administered taxane, paclitaxel, is one of the most commonly employed agents for the treatment of both localized and advanced breast cancer. tesetaxel is an orally administered taxane that is in development as first- and second-line treatment for patients with advanced cancers. this study is being undertaken to determine the efficacy and safety of tesetaxel administered as first-line therapy to patients with metastatic breast cancer.


Eligibility criteria:
primary inclusion criteria: * female * at least 18 years of age * histologically or cytologically confirmed adenocarcinoma of the breast * stage iv disease * her2 status negative * measurable disease (revised recist; version 1.1) * eastern cooperative oncology group performance status 0 or 1 * life expectancy of at least 3 months * chemotherapy naïve or 1 prior chemotherapy regimen in the adjuvant setting (prior taxane-based adjuvant therapy allowed provided patient had a disease-free interval of at least 12 months after completing this adjuvant therapy) * prior hormonal therapy, aromatase inhibitor therapy, and immunotherapy allowed * prior radiotherapy in the adjuvant setting allowed provided that less than 25% of the bone marrow had been irradiated * adequate bone marrow, hepatic, and renal function, as specified in the protocol * at least 4 weeks and recovery from effects of prior surgery, hormonal therapy, aromatase inhibitor therapy, immunotherapy, radiotherapy, or other therapy with an approved or investigational agent * ability to swallow an oral solid-dosage form of medication primary exclusion criteria: * known metastasis to the central nervous system * history of other malignancy within the last 5 years other than curatively treated basal and squamous cell carcinoma of the skin or carcinoma of the cervix in situ * significant medical disease other than stage iv breast cancer * presence of neuropathy \> grade 1 (nci ctc, version 4.0) * history of hypersensitivity to a taxane * need to continue any regularly-taken medication that is a potent inhibitor or inducer of the cyp3a pathway or p-glycoprotein activity

Keywords: metastatic breast cancer first-line therapy tesetaxel oral taxane
a study to evaluate itca 650 compared to sitagliptin as add-on therapy for the treatment of type 2 diabetes

Conditions: Type 2 Diabetes

Summary: phase 3 study to compare treatment with itca 650 to sitagliptin when added to metformin monotherapy in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * hba1c between 7.5% - 10.5% * on metformin monotherapy * bmi between 25 \& 45 kg/m2 exclusion criteria: * taking thiazolidinedione, sulfonylurea, dpp-4, exenatide, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months * history of pancreatitis
haic with folfox versus systemic chemotherapy with gp for unresectable icc

Conditions: Intrahepatic Cholangiocarcinoma

Summary: the purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (haic) of oxaliplatin, 5-fluorouracil and leucovorin compared systemic chemotherapy of gemcitabine and cisplatin in patients with unresectable intrahepatic cholangiocarcinoma.


Eligibility criteria:
inclusion criteria: * the diagnosis of icc * patients must have at least one tumor lesion that can be accurately measured according to mrecist criteria. * with no previous treatment * no cirrhosis or cirrhotic status of child-pugh class a only * not amendable to surgical resection ,local ablative therapy and any other cured treatment. * without distant metastasis, but intrahepatic lymph node metastasis is allowed * the following laboratory parameters: platelet count ≥ 50,000/μl hemoglobin ≥ 8.5 g/dl total bilirubin ≤ 30mmol/ l serum albumin ≥ 32 g/l asl and ast ≤ 6 x upper limit of normal serum creatinine ≤ 1.5 x upper limit of normal inr ≤ 1.5 or pt/aptt within normal limits absolute neutrophil count (anc) \>1,500/mm3 exclusion criteria: * evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * known history of hiv * history of organ allograft * known or suspected allergy to the investigational agents or any agent given in association with this trial. * cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * evidence of bleeding diathesis. * patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * known central nervous system tumors including metastatic brain disease

Keywords: intrahepatic cholangiocarcinoma systemic chemotherapy hepatic artery infusion chemotherapy
role of non-selective beta-adrenergic blocker in severe tbi

Conditions: Traumatic Brain Injury (TBI) Patients; Intracranial Pressure; Intensive Care Unit; Mortality

Summary: the role of nonselective beta adrenergic blocker as antistress agent in severe traumatic brain injury

the primary injury occurs at the time of trauma. secondary injury is caused by complications of the primary insult and caused by processes such as hypoxia, cerebral edema and ischemia. severe traumatic brain injury is associated with increased intracranial pressure, activation of the sympathetic nervous system and catecholamine response and major morbidity and mortality . β-blockade is just one pharmacologic strategy to reduce sympathetic hyperactivity. in the intensive care unit patients with severe traumatic brain injury associated with restlessness and agitation are frequently sedated and intubated in order to reduce the workload of the brain. this hyperactive response is called sympathetic storming which occurs within 24 hours of brain injury or weeks later . it occurs due to acceleration in sympathetic nervous system activity in the central nervous system which results in loss of cortical control due to downregulation of autonomic balance in the brain injury . a non-selective beta-adrenergic antagonist propranolol, is one of the most customarily used treatments in the case of paroxysmal sympathetic hyperactivity.

Eligibility criteria:
inclusion criteria: * patients aged between 18and 65 years old * patients who have severe traumatic brain injury * glascow outcome scale ≤ 8 exclusion criteria: * patients have pre-existing heart disease. * if there are contraindications to β blocker. * penetrating traumatic brain injury. * pre-injury brain dysfunction. * β-blocker or α2-agonist use before trauma.
study comparing pulmonary vein isolation with the cryoballoon and radiofrequency energy(contact force) in the treatment of persistent atrial fibrillation (af) (cryo vs cf in peraf)

Conditions: Persistent Atrial Fibrillation

Summary: the purpose of this study is to perform a prospective, randomised study investigating the safety and efficacy of cryoballoon catheter ablation compared with radiofrequency ablation(contact force), in the treatment of persistent af.

the hypotheses for this study is that cryothermal energy is as effective and safe as using radiofrequency energy in the treatment of persistent af and is associated with a better long term outcome.

Eligibility criteria:
inclusion criteria: * persistent atrial fibrillation; intolerant to antiarrhythmic medication; both male or female; age from 18 to 75 years old. exclusion criteria: * acute myocardial infarction; coronary artery stent history; acute severe stroke; abnormal liver and renal function.

Keywords: cryoballoon contact force persistent atrial fibrillation